Devices, systems and methods for patient infusion

ABSTRACT

A device for delivering a fluid to a patient, including an exit port, a dispenser for causing fluid from a reservoir to flow to the exit port, a local processor programmed to cause a flow of fluid to the exit port based on flow instructions from a separate, remote control device, and a wireless receiver connected to the local processor for receiving the flow instructions. The device also includes a housing free of user input components for providing flow instructions to the local processor, in order to reduce the complexity and costs of the device so that the device lends itself to being disposable in nature. A system and a kit are also described that include the fluid delivery device, a separate, remote control device, and accessories for transcutaneous delivery of fluid medications. Methods of utilizing the fluid delivery device to infuse fluid medications are additionally disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a division of application Ser. No. 09/943,992, filed Aug. 31,2001, now U.S. Pat. 6,740,059 claims priority to provisional U.S. patentapplication Ser. No. 60/231,476, filed on Sep. 8, 2000, which isassigned to the assignee of the present application and incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods, and more particularly to small, low cost, portable infusiondevices and methods that are useable to achieve precise, sophisticated,and programmable flow patterns for the delivery of therapeutic liquidsto a mammalian patient.

BACKGROUND OF THE INVENTION

Today, there are numerous diseases and other physical ailments that aretreated by various medicines including pharmaceuticals, nutritionalformulas, biologically derived or active agents, hormonal and gene basedmaterial and other substances in both solid or liquid form. In thedelivery of these medicines, it is often desirable to bypass thedigestive system of a mammalian patient to avoid degradation of theactive ingredients caused by the catalytic enzymes in the digestivetract and liver. Delivery of a medicine other than by way of theintestines is known as parenteral delivery. Parenteral delivery ofvarious drugs in liquid form is often desired to enhance the effect ofthe substance being delivered, insuring that the unaltered medicinereaches its intended site at a significant concentration. Also,undesired side effects associated with other routes of delivery, such assystemic toxicity, can potentially be avoided.

Often, a medicine may only be available in a liquid form, or the liquidversion may have desirable characteristics that cannot be achieved withsolid or pill form. Delivery of liquid medicines may best beaccomplished by infusing directly into the cardiovascular system viaveins or arteries, into the subcutaneous tissue or directly into organs,tumors, cavities, bones or other site specific locations within thebody.

Parenteral delivery of liquid medicines into the body is oftenaccomplished by administering bolus injections using a needle andsyringe, or continuously by gravity driven dispensers or transdermalpatch technologies. Bolus injections often imperfectly match theclinical needs of the patient, and usually require larger individualdoses than are desired at the specific time they are given. Continuousdelivery of medicine through gravity feed systems compromise thepatient's mobility and lifestyle, and limit the therapy to simplisticflow rates and profiles. Transdermal patches have special requirementsof the medicine being delivered, particularly as it relates to themolecular structure, and similar to gravity feed systems, the control ofthe drug administration is severely limited.

Ambulatory infusion pumps have been developed for delivering liquidmedicaments to a patient. These infusion devices have the ability tooffer sophisticated fluid delivery profiles accomplishing bolusrequirements, continuous infusion and variable flow rate delivery. Theseinfusion capabilities usually result in better efficacy of the drug andtherapy and less toxicity to the patient's system. An example of a useof an ambulatory infusion pump is for the delivery of insulin for thetreatment of diabetes mellitus. These pumps can deliver insulin on acontinuous basal basis as well as a bolus basis as is disclosed in U.S.Pat. No. 4,498,843 to Schneider et al.

The ambulatory pumps often work with a reservoir to contain the liquidmedicine, such as a cartridge or syringe, and use electro-mechanicalpumping or metering technology to deliver the medication to the patientvia tubing from the infusion device to a needle that is insertedtranscutaneously, or through the skin of the patient. The devices allowcontrol and programming via electromechanical buttons or switcheslocated on the housing of the device, and accessed by the patient orclinician. The devices include visual feedback via text or graphicscreens, such as liquid crystal displays known as LCD's, and may includealert or warning lights and audio or vibration signals and alarms. Thedevice can be worn in a harness or pocket or strapped to the body of thepatient.

Currently available ambulatory infusion devices are expensive, difficultto program and prepare for infusion, and tend to be bulky, heavy andvery fragile. Filling of these devices or their reservoirs can bedifficult and require the patient to carry both the intended medicationas well as filling accessories when traveling or even just going towork. The accuracy and safety requirements of these devices areextremely important, based both on the medicine being delivered and thecondition of the patient. Therefore, the devices require specializedcare, maintenance and cleaning to assure proper functionality and safetyfor their intended long term use. The devices are usually sold for$4,000 to $6,000 requiring maintenance of the device for four or moreyears to justify the expenditure. Also due to the cost, replacementdevices are not easily available or practical. Any damage to the device,such as that caused by it being dropped, result not only in the costs ofrepair or replacement, but also in a period of discontinued therapy. Thehigh cost of the device is a concern of healthcare providers who approveand prescribe the use of the device, limiting the expansion of thepatient populations and therapies for which the devices can be used.

Clearly, therefore, there is a need for a programmable and adjustableinfusion system that is precise and reliable and can offer cliniciansand patients a small, low cost, light weight, simple to use alternativefor parenteral delivery of liquid medicines.

SUMMARY OF THE INVENTION

The applicant has determined that a sophisticated ambulatory infusiondevice that can be programmed to reliably deliver variable flow profilesof liquid medications, yet is small, light weight and low cost, isneeded. Smaller and lighter devices are easier to carry and are morecomfortable for the patient, even allowing the device to be adhesivelyattached to the patient's skin similar to a transdermal patch. Aninexpensive device allows greater flexibility in prescribing the devicefor use by reducing the financial burden on healthcare insuranceproviders, hospitals and patient care centers, as well as patientsthemselves. In addition, low cost devices make more practical themaintenance of one or more replacement devices. If the primary device islost or becomes dysfunctional, availability of the replacement avoidscostly expedited repair and down time.

Aspects of the present invention will enable cost reductions significantenough to make the entire device disposable in nature, being replaced asfrequently as every two to five days. A disposable device allows themedication to be prefilled by the manufacturer and does not need theroutine cleaning and maintenance required by long term devices, greatlysimplifying use for the patient. Similar to disposable cameras whichhave become increasingly popular in recent years, another benefit isthat each time a disposable fluid delivery device is purchased, it isthe latest or state of the art technology. Long term use devices may beoutdated in a year when a new version is available from themanufacturer, just twenty five percent of the life expectancy of theoriginal device.

The present invention, therefore, provides a device for delivering fluidto a patient, including an exit port assembly adapted to connect to atranscutaneous patient access tool, a dispenser for causing fluid from areservoir to flow to the exit port assembly, a local processor connectedto the dispenser and programmed to cause a flow of fluid to the exitport assembly based on flow instructions from a separate, remote controldevice, and a wireless receiver connected to the local processor forreceiving the flow instructions from a separate, remote control deviceand delivering the flow instructions to the local processor. The devicealso includes a housing containing the exit port assembly, thedispenser, the local processor, and the wireless receiver. The housingis free of user input components for providing flow instructions to thelocal processor in order to reduce the size, complexity and costs of thedevice, such that the device lends itself to being disposable in nature.

According to one aspect of the present invention, the flow instructionscause a predetermined rate of fluid flow for a predetermined period.According to another aspect, the predetermined rate of fluid flowcomprises a basal rate.

According to another aspect of the present invention, the flowinstructions cause a predetermined volume of fluid to flow for apredetermined period. According to an additional aspect, thepredetermined volume comprises a bolus volume.

According to an additional aspect, the device includes a least one userinterface component accessible from an exterior of the housing forcausing a predetermined volume of fluid to flow for a predeterminedperiod, independently of the local processor. According to a furtheraspect, the device includes a least one user interface componentaccessible from an exterior of the housing for occluding flow to theexit port assembly.

According to another aspect of the present invention, the deviceincludes a power supply connected to the local processor. According toan additional aspect, the device includes a transmitter connected to thelocal processor for transmitting information from the local controllerto a separate, remote control device. According to still a furtheraspect, the housing is free of user output components for providinginformation from the local processor. According to a further aspect, theexit port assembly includes a tubular member for transcutaneouslyentering a patient. According to still a further aspect, the deviceincludes a reservoir.

The present invention also provides a system including a fluid deliverydevice as described above, and further including a separate, remotecontrol device including a remote processor, user input componentsconnected to the remote processor for allowing a user to provideinstructions to the remote controller, and a transmitter connected tothe remote controller for transmitting the instructions to the receiverof the fluid delivery device. Thus, the remote controller allows a user,such as a patient, nurse or doctor, to remotely program the fluiddelivery device to provide a desired infusion of fluid into the patient.

The present invention further provides another device for deliveringfluid to a patient, including an exit port assembly adapted to connectto a transcutaneous patient access tool, a dispenser for causing fluidfrom a reservoir to flow to the exit port assembly, a local processorconnected to the dispenser and programmed to cause fluid flow to theexit port assembly based upon flow instructions. The local processor isalso programmed to provide flow information, and a wireless transmitteris connected to the local processor for transmitting the flowinformation to a separate, remote control device. A housing contains theexit port assembly, the dispenser, the local processor, and the wirelesstransmitter, and is free of user output components for providing theflow information from the local processor to a user.

These aspects of the invention together with additional features andadvantages thereof may best be understood by reference to the followingdetailed descriptions and examples taken in connection with theaccompanying illustrated drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectional side view of a first exemplary embodiment of afluid delivery device in accordance with this invention;

FIG. 2 is a perspective view of an exemplary embodiment of a remotecontrol device in accordance with this invention for use with the fluiddelivery device of FIG. 1;

FIG. 3 is a sectional side view of a second exemplary embodiment of afluid delivery device in accordance with this invention;

FIG. 3 a is an enlarged partial sectional view of a dispenser for thedevice of FIG. 3, shown with an accumulator empty and ready to be filledupon an inlet valve being opened;

FIG. 3 b is an enlarged sectional view of the dispenser for the deviceof FIG. 3, shown with the accumulator filled and ready to dispense apulse of fluid upon an outlet valve being opened;

FIG. 4 is a sectional side view of a third exemplary embodiment of afluid delivery device in accordance with this invention;

FIG. 4 a is an enlarged sectional side view of a reservoir chamber ofthe device of FIG. 4;

FIG. 4 b is an enlarged bottom plan view of a portion of the reservoirchamber of the device of FIG. 4;

FIG. 5 is a sectional side view of a fourth exemplary embodiment of afluid delivery device in accordance with this invention;

FIG. 5 a is a bottom plan view of the device of FIG. 5;

FIG. 6 is a sectional side view of a fifth exemplary embodiment of afluid delivery device shown positioned on an outer surface of skin andsubcutaneous tissue of a patient;

FIG. 6 a is a bottom plan view of the device of FIG. 6;

FIG. 7 is a sectional side view of a sixth exemplary embodiment of afluid delivery device in accordance with the present invention;

FIG. 8 is a sectional side view of a seventh exemplary embodiment of afluid delivery device in accordance with the present invention;

FIG. 8 a is a top plan view of the device of FIG. 8;

FIG. 9 is a sectional side view of an eighth exemplary embodiment of afluid delivery device in accordance with the present invention;

FIG. 9 a is a perspective view of an infusion set compatible with anoutlet assembly of the device of FIG. 9;

FIG. 10 is a sectional side view of a ninth exemplary embodiment of afluid delivery device in accordance with the present invention, with amechanical stop button of the device shown in the open position;

FIG. 10 a is an enlarged sectional view of the stop button assembly ofthe device of FIG. 10 with the button shown in the closed position;

FIG. 11 is a sectional side view of a tenth exemplary embodiment of afluid delivery device in accordance with the present invention;

FIG. 11 a is an enlarged sectional view of a bolus button assembly ofthe device of FIG. 11;

FIG. 12 is a perspective view of another exemplary embodiment of aremote control device in accordance with the present invention;

FIG. 12 a is a sectional side view of the remote control device of FIG.12;

FIG. 13 is a top plan view of an eleventh exemplary embodiment of afluid delivery device in accordance with the present invention;

FIG. 13 a is a top plan view of a remote controller to be combined withthe fluid delivery device of FIG. 13 as part of a kit in accordance withthe present invention;

FIG. 13 b is a top plan view of an insulin cartridge to be combined withthe fluid delivery device of FIG. 13 as part of a kit in accordance withthe present invention; and

FIG. 13 c is a top plan view of a sterile infusion set to be combinedwith the fluid delivery device of FIG. 13 as part of a kit in accordancewith the present invention.

Like reference characters designate identical or correspondingcomponents and units throughout the several views.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Set forth hereinbelow are detailed descriptions of certain embodimentsand examples of fluid delivery devices, systems and kits, constructed inaccordance with the present invention, as well as methods for using thedevices, systems and kits. The types of liquids that can be delivered bythe fluid delivery devices, systems and kits of the present inventioninclude, but are not limited to, insulin, antibiotics, nutritionalfluids, total parenteral nutrition or TPN, analgesics, morphine,hormones or hormonal drugs, gene therapy drugs, anticoagulants,analgesics, cardiovascular medications, AZT or chemotherapeutics. Thetypes of medical conditions that the fluid delivery devices, systems andkits of the present invention might be used to treat include diabetes,cardiovascular disease, pain, chronic pain, cancer, AIDS, neurologicaldiseases, Alzheimer's Disease, ALS, Hepatitis, Parkinson's Disease orspasticity.

In FIG. 1, there is illustrated, generally at 10, a fluid deliverydevice according to the invention. The device 10 generally includes anexit port assembly 70 adapted to connect to a transcutaneous patientaccess tool, a dispenser 40 for causing fluid from a reservoir 30 toflow to the exit port assembly, a processor or electronicmicrocontroller (hereinafter referred to as the “local” processor) 50connected to the dispenser and programmed to cause a flow of fluid tothe exit port assembly based on flow instructions from a separate,remote control device (an example of which is shown in FIG. 2), and awireless receiver 60 connected to the local processor for receiving theflow instructions from the separate, remote control device anddelivering the flow instructions to the local processor. The device alsoincludes a housing 20 containing the exit port assembly 70, thedispenser 40, the local processor 50, and the wireless receiver 60. Thehousing 20 is free of user input components, such as external buttonsconnected to the processor 50, for providing flow instructions to thelocal processor 50 in order to reduce the size, complexity and costs ofthe device 10, such that the device lends itself to being small anddisposable in nature.

In the exemplary embodiment of FIG. 1, the device 10 also includes areservoir 30 contained within the housing 20 and connected to thedispenser 40. The reservoir 30 is provided with a collapsible designsuch as a metal bellows or is made of a collapsible material such as asilicone elastomer. The volume of the reservoir 30 is chosen to bestsuit the therapeutic application of the fluid delivery device 10impacted by such factors as available concentrations of medicinal fluidsto be delivered, acceptable times between refills or disposal of thefluid delivery device 10, size constraints and other factors. Fortreatment of Type I diabetics, for example, a reservoir of less than 5ml, and preferably 2 to 3 ml, is appropriate.

The local processor 50 contains all the computer programs and electroniccircuitry needed to allow a user to program the desired flow patternsand adjust the program as necessary. Such circuitry can include one ormore microprocessors, digital and analog integrated circuits, resistors,capacitors, transistors and other semiconductors and other electroniccomponents known to those skilled in the art. The local processor 50also includes programming, electronic circuitry and memory to properlyactivate the dispenser at the needed time intervals. In the exemplaryembodiment of FIG. 1, a power supply 80, such as a battery or capacitor,is included and supplies power to the local processor 50.

When the local processor 50 activates the dispenser 40, a specificamount of fluid exits the fluid delivery device 10 via the exit portassembly 70. The exit port assembly 70 can include elements totranscutaneously enter the patient, such as a needle or soft cannula, orcan be adapted to connect to a standard infusion device that includestranscutaneous delivery means.

As shown, the housing 20 is free of user input components for providingflow instructions to the local processor 50, such as electromechanicalswitches or buttons on an outer surface 21 of the housing, or interfacesotherwise accessible to a user to adjust the programmed flow ratethrough the local processor 50. In order to program, adjust theprogramming of, or otherwise communicate user inputs to the localprocessor 50, the fluid delivery device 10 includes the wirelesscommunication element, or receiver 60 for receiving the user inputs froma separate, remote control device, such as the separate, remote controldevice 100 of FIG. 2. Signals can be sent via a communication element(not shown) of the remote control device 100, which can include or beconnected to an antenna 130, shown in FIG. 2 as being external to thedevice 100.

The remote control device 100 has user input components, including anarray of electromechanical switches, such as the membrane keypad 120shown. The control device 100 also includes user output components,including a visual display, such as a liquid crystal display (LCD) 110.Although not shown in FIG. 2, the remote control device 100 has its ownprocessor (hereinafter referred to as the “remote” processor) connectedto the membrane keypad 120 and the LCD 110. The remote processor isprogrammed to receive the user inputs from the membrane keypad 120 andtranslate the user inputs into “flow” instructions for transmission tothe fluid delivery device 10, and is programmed to send user outputs tothe LCD 110.

A user, such as a patient or a clinician, can thus program the fluiddelivery device 10 by entering information into the remote controldevice 100, which then downloads information to the receiver 60 of thedevice 10 with each key stroke or button pressed or in a batch mode ofmultiple key strokes. Complex flow algorithms, requests for bolusdelivery and other desired infusions of the medicinal fluid can beaccomplished by entering information into the remote control device 100,which is then transmitted to the fluid delivery device 10. Thecommunication can be confirmed as acceptable by the local processor 50of the fluid delivery device 10 by using one or more features such asstandard handshaking protocols, redundant transmissions and othercommunication confirmation methods, as are known to those skilled in theart.

The lack of user interfaces, such as electromechanical switches on thefluid delivery device 10, results in substantial reductions in the cost,the size, and the weight of the device 10. The lack of user interfacesalso allows the housing outer surface 21 of the device 10 to berelatively smooth, thereby simplifying cleaning and preventing jewelryor clothing items such as sweaters from catching on the device. Sincethe remote control device 100 also includes a visual display 110, thefluid delivery device 10 can be void of an information screen, furtherreducing cost, size and weight. Lack of user interfaces, such aselectromechanical switches and information screens, greatly simplifiesthe design of the fluid delivery device 10 and allows the device 10 tobe made more flexible and resistant to damage.

FIG. 3 shows another exemplary embodiment of the fluid delivery device10 of the present invention wherein the reservoir 30 is made of aflexible material and is enclosed in a reservoir chamber 35, which canbe defined by the housing 20 and housing reservoir walls 27. Theflexible reservoir 30 is placed in compression by a compressing member33 and compressing springs 34, which are positioned between thecompressing member 33 and the housing 20. The compressed, flexiblereservoir 30 causes fluid inside the reservoir 30 to be at a pressureabove atmospheric pressure. In a preferred embodiment, a cross sectionalarea of the compressing member 33 approximates a cross sectional area ofthe reservoir 30.

Alternatively, the housing 20 may include a flexible cantilever beamthat contacts the reservoir 30 creating a pressure within the reservoir30 above atmospheric pressure. In another alternative, the reservoirchamber 35 may be sealed and filled with a gas, or a vapor-plus-fluidmixture, to place the fluid within the reservoir 30 under pressure aboveatmospheric pressure. The gas can be air, and the vapor-plus-fluidmixture can be Freon. The Freon vapor-plus-fluid mixture provides thedesign advantage of near constant pressure if the fluid delivery device10 is maintained at near constant temperature. In still anotheralternative embodiment, the amount of gas placed in a sealed reservoirchamber 35 may be chosen such that the reservoir 30 pressure is equal toor less than atmospheric for the entire full to empty conditions of thereservoir 30. If the fluid in the reservoir 30 is maintained at apressure equal to or below atmospheric, then the dispenser 40 isprovided in the form of a pump, such as a peristaltic drive pump, forpumping fluid from the reservoir 30 to the outlet port assembly 70.

The reservoir 30 may be prefilled by the device manufacturer or acooperating drug manufacturer, or may include external filling meansconsisting of a fill assembly 31. If the fluid delivery device 10 isprefilled by the manufacturer, the local processor 50 can be providedwith memory containing various information regarding the prefilled drugincluding but not limited to, the type or name and the concentration andvolume of the fluid.

The fill assembly 31 can include a needle insertion septum 32. Thereservoir 30 and other fluid path components may be placed in a vacuumduring the final manufacturing process to simplify filling and primingof the fluid delivery device 10 for the patient. Needle insertion septum32 may be constructed of a resealing elastomer such as silicone thatallows a needle to puncture septum to add fluid to the reservoir 30, yetreseal after the needle is withdrawn. An alternative to the needleinsertion septum 32 is a standard fluid connection, such as a Luerconnector, which can be affixed to the fill assembly 31 in combinationwith a one way valve such as a duck bill valve (not shown). The patientcould attach a syringe filled with the liquid medication to the Luerconnector and fill the fluid delivery device 10. The fill assembly 31may be designed so that the patient can fill the fluid delivery device10 one time only, such as by having the Luer connection break off whenthe syringe is removed.

The dispenser 40 is connected in fluid communication with the reservoir30. When the device 10 is provided with a pressurized reservoir 30, asshown in exemplary embodiment of FIG. 3, the dispenser can include aninlet valve 41 connected to the reservoir, and outlet valve 42 connectedto the exit port assembly 70, and an accumulator 43 connected betweenthe inlet valve and the outlet valve. Since the fluid in the reservoir30 is maintained at a pressure above atmospheric pressure, opening ofthe inlet valve 41 allows the accumulator to fill to the reservoirpressure, after which the inlet valve is 41 is closed. At the propertime, as determined by the local processor 50 programming andinstructions received from the remote control device, the outlet valve42 can be opened to dispense fluid to the exit port assembly 70, whichis at the pressure of the patient, or atmospheric pressure. Theaccumulator 43 will then be at atmospheric pressure, and the outletvalve 42 can be closed, ready for another repeat cycle.

The dispenser 40 of the exemplary embodiment of FIG. 3 does not create adriving or pumping force on the fluid passing therethrough, but ratheracts as a metering device, allowing pulses of fluid to pass from thepressurized reservoir 30, through the dispenser 40, to the exit portassembly 70 at atmospheric pressure. The inlet valve 41 and the outletvalve 42 of the dispenser 40 are controlled by the local processor 50,which includes electronic programming, controls and circuitry to allowsophisticated fluid delivery programming and control of the dispenser40.

FIG. 3 a shows the dispenser 40 with the accumulator 43 at atmosphericpressure. An accumulator membrane 44 is shown in its non-distendedstate, caused by atmospheric pressure only. Inlet valve 41 is closed,and outlet valve 42 may be open or closed, but must have been openedsince the last time inlet valve 41 was opened. FIG. 3 b shows thecondition where outlet valve 42 is closed, and inlet valve 41 has beenopened. Because of the elevated pressure of the fluid from the reservoir30, the accumulator membrane 44 is distended, thus increasing the volumeof accumulator 43 by an accumulator volume 45. After the inlet valve 41is closed, the outlet valve 42 can be opened, to dispense theaccumulator volume 45 and allow the accumulator membrane 44 to retractto the position shown in FIG. 3 a.

The inlet valve 41 and the outlet valve 42 of the dispenser 40 and thelocal processor 50 are designed to prevent both valves from being openedat the same time, precluding the reservoir 30 to ever flow directly tothe exit port assembly 70. The prevention of both valves opening at thesame time is critical and can be accomplished via mechanical means,electrical means, or both. The prevention can be accomplished in thedispenser 40 design, the local processor 50 design, or both.

The dispenser 40 shown in FIGS. 3, 3 a and 3 b dispenses finite pulsesof fluid volume, called pulse volume (PV), with each activation. The PVis determined by the properties, materials and construction of theaccumulator 43 and the accumulator membrane 44. PV's delivered byinfusion devices are typically chosen to be small relative to what wouldbe considered a clinically significant volume. For insulin applicationsat a concentration of 100 units per ml, a PV of less than 2 microliter,and typically 0.5 microliter, is appropriate. If the fluid deliverydevice 10 is programmed via the remote control device 100 to deliver 2units an hour, the dispenser will deliver 40 pulses an hour, or a pulseevery 1.5 minutes. Such pulsitile flow is considered continuous if thePV is small enough. Other drugs or concentrations may permit a muchlarger PV. Various flow rates are achieved by adjusting the time betweenpulses. To give a fixed volume or bolus, multiple pulses are given inrapid succession until the bolus volume is reached.

The PV may not always be constant enough to be within the accuracyrequirements of the fluid delivery device 10. One factor impacting thePV is reservoir pressure. The fluid delivery device 10 may include meansfor monitoring reservoir pressure (RP) and adjust the timing betweenpulses to achieve the desire flow pattern. An example of suchcompensation would be to decrease time between pulses as the PVdecreases to maintain the programmed flow rate. Means for monitoringsuch parameters as reservoir pressure RP are described below. Analternative to monitoring reservoir pressure is monitoring the volume ofthe reservoir 30. Each time a pulse or series of pulses are delivered, ameasurement of reservoir volume can indicate whether a proper amount offluid has been delivered, both for individual pulses and cumulativepulses. The system could also be designed to compensate fluid flow aserrors are detected. An example of a reservoir volume transducer meansis also described below.

The communication element 60 preferably receives electroniccommunication from the remote control device 100 using radio frequencyor other wireless communication standards and protocols. The informationtransferred includes codes or packets of codes that the local processor50 uses to confirm that the information was received correctly, similarto the way standard telephone modem communication is performed. Moresophisticated codes can be included to allow the information to beself-corrected or pinpoint the area of bad information. In an even morepreferred embodiment, the communication element 60 is a two-waycommunication element, including a receiver and a transmitter, forallowing the fluid delivery device 10 to send information back to theremote control device 100. In such an embodiment, the remote controldevice 100 also includes an integral communication element 60 comprisinga receiver and a transmitter, for allowing the remote control device 100to receive the information sent by the fluid delivery device 10.

The power supply 80 can be integrated into the fluid delivery device 10and not accessible to a user. In an alternative embodiment, however, thepower supply 80 can be replaceable, e.g., a replaceable battery. Inanother embodiment, the power supply 80 can comprise an integratedbattery or capacitor, for low power components of the device 10 such asthe electronic memory, and a user-inserted battery for powering theremainder of the device 10. Other components that may require electricalenergy are the communication element 60, the dispenser 40, and othercomponents such as sensors or transducers.

As shown in FIG. 3, the device can include sensors or transducers suchas a reservoir volume transducer 37. A similar transducer is describedin U.S. Pat. No. 5,533,389 to Kamen et al. FIG. 3 also shows a pressuretransducer 221, located on the housing reservoir walls 27 and in contactwith a portion of the reservoir 30. The pressure transducer 221 mayconsist of force sensing resistor technology such as that manufacturedby Interlink, Inc. of Camarillo, Calif. Reservoir transducer 37 orpressure transducer 221 can transmit information to local processor 50to indicate how and when to activate the dispenser 40, or to indicateother parameters determining flow, as well as conditions such as thereservoir 30 being empty or leaking, or the dispensing of too much ortoo little fluid from the reservoir, etc.

FIG. 4 shows another exemplary embodiment of the fluid delivery device10 including an elastic sock 36 for compressing the reservoir 30 to apressure above atmospheric pressure. The reservoir sock 36, constructedof an elastic material, has a very small unexpanded internal volume, nolarger than the volume of reservoir 30 in its empty state. The reservoirsock 36 expands to support reservoir 30 when full, and elasticallycompresses until reservoir 30 is fully empty. Alternatively, the elasticreservoir 30 can be provided with a very small internal volume whenempty, typically less than 100 microliters, and that expands during thefill process, creating a pressure within the reservoir greater thanatmospheric pressure until the reservoir 30 is again empty, therebyobviating the need for the reservoir sock 36. The fluid delivery device10 of FIG. 4 also includes a Luer connector 71 for attaching a standardtranscutaneous fluid delivery set to the exit port assembly 70.

Since the fluid delivery device 10 may be worn close to or even attachedto the body of a mammalian patient, it may be desired to prevent thetemperature of the fluid in the reservoir 30 from elevating toward thebody temperature of the patient. In one embodiment, the reservoirchamber 35 can be sealed and placed in a vacuum, similar to constructionof a thermos bottle. The internal surface of the reservoir chamber 35can be coated with reflective material, also similar to a thermosbottle. Alternatively, the chamber 35 can be filled with insulatingmaterial such as a low thermal conductance foam, with sufficient cavitysize to allow the reservoir 30 to expand to a maximum fill capacity.Shown in FIGS. 4 a and 4 b are venting holes 38, placed through thehousing 20 and housing outer surface 21 in the area of reservoir chamber35 on the side of the device 10 away from the skin of the patient. Theventing holes 38 allow the reservoir chamber 35 to vent to ambienttemperature and thus help cool the reservoir 30.

FIG. 5 shows another exemplary embodiment of the fluid delivery device10 that includes a second reservoir 90 in fluid communication with asecond dispenser 91. The additional reservoir 90 can be filled duringthe manufacturing process or can include filling means similar to thefill assembly 31. The additional dispenser 91 may include a separatecontroller, or can be controlled by the same local processor 50. Theadditional dispenser 91 connects distally to tubing lumen 74 extendingbetween the main dispenser 40 and the exit port assembly 70. Similar tothe main dispenser 40, the additional dispenser 91 is designed andcontrolled to prevent free flow of fluid from the additional reservoir90 to the exit port assembly 70.

The second reservoir 90 may be filled with a drug different from thedrug in the main reservoir 30, a diluent of the drug in the mainreservoir 30 or any inert substance. The fluid from the additionalreservoir 90 may be administered to dilute the fluid dispensed from themain reservoir 30, to provide more sophisticated or additive therapies,or even to maintain patency of the transcutaneous fluid path by flowingan inert substance at a more frequent rate then the intended infusion ofthe fluid in the main reservoir 30.

Referring also to FIG. 5 a, the device also includes a transcutaneouspatient access tool comprising transcutaneous micropenetrators 75connected to the exit port assembly 70. The transcutaneousmicropenetrators 75 include a series of micro-needles or othermicropenetrators that allow fluid to transcutaneously enter the body ofthe patient without standard needles. Similar transcutaneousmicropenetrators are shown, for example, in U.S. Pat. No. 5,983,136 toKamen et al.

The device 10 further includes an adhesive layer 201 on the outersurface 21 of the housing 20 for securing the device 10 directly to theskin of a patient. The adhesive layer is preferably provided in acontinuous, oval shape encircling the exit port assembly 70 in order toprovide a protective seal around the penetrated skin. The housingadhesive layer 201 can consist of material such as that used in bandagesor electro surgery return pads such as those manufactured by the ValleyLab division of Tyco/U.S. Surgical.

FIGS. 6 and 6 a show another exemplary embodiment of the fluid deliverydevice 10 including a housing 200 having a recessed surface 29 forcreating an air pocket between the fluid delivery device 10 and the skin210 of a patient. The device 10 also includes a secondary adhesive layer202 attached to the first adhesive layer 201, which is attached to thebottom surface of the housing 200 surrounding the recessed surface 29.The secondary adhesive layer 202 allows the device 10 to be attached,removed and attached again to a patient. When first attached, thesecondary adhesive layer 202 adheres to the skin 210. Upon removal ofthe device 10, the secondary adhesive layer 202 can be removed from thefirst adhesive layer 201, and the fluid delivery device 10 can then bereattached to the skin 210 using the adhesive layer 201.

A needle connection tubing 73 terminating in a skin penetrating cannula72 is shown connected to the exit port assembly 70. The needleconnection tubing 73 is flexible, allows various placements and can bereinforced to prevent kinking. Reinforcement can be accomplished throughchoice of materials and ratio of wall thickness to inner diameter, orthe tubing 73 can be reinforced with an internal wire coil. The skinpenetrating cannula 72 can be a rigid member, such as a needle, or canbe flexible. The skin penetrating cannula 72 is inserted through theskin 210 prior to attaching the fluid delivery device 10 to the skin 210and may be inserted using a needle insertion assistance mechanism. Sucha needle insertion assistance mechanism may be integrated into the fluiddelivery device 10, or can be supplied as a separate mechanism. FIG. 6shows the cannula 72 entering through the surface of the skin 210 andentering subcutaneous tissue 211. Once the fluid delivery device 10 isattached to the skin 210, the needle connecting tube 73 remainsrelatively stable due to the direct connection between the device 10 andthe skin 210. This stability helps prevent kinking of the tubing 73 andresultant occlusion, which is common to other ambulatory devices.

FIG. 7 shows another exemplary embodiment of the fluid delivery device10 including sensors providing feedback to the local processor 50, anelectronic assembly for the various electronic devices and an optionalsecond power supply 83. The sensors include a volume sensor 222, forexample, provided in proximity with the reservoir 30 and an occlusionsensor 220 in proximity with the exit port tubing lumen 74.

The microcontroller 50 can include a microprocessor 51, memory 52, anelectronic clock oscillator 53, an analog-to-digital converter 54 and amultiplexer 55. Also shown in FIG. 7 is the optional secondary powersource 83, attached by the user to a battery connector 81 connected tothe microcontroller 50. A battery door 82 is removed for insertion ofthe battery 83 and then reattached by sliding the door in direction D1to the housing 20 of the fluid delivery device 10. In a preferredembodiment, the power supply 80 provides electrical power for memoryretention and low power electronics only, while the secondary powersource 83 provides electrical power for higher consumption components ofthe device 10, such as the dispenser 40. Both the power supply 80 andthe secondary power source 83 may be consumer batteries, such asalkaline or nickel cadmium batteries, or other energy storage devicessuch as a capacitor. Additionally, both the power supply 80 and thesecondary power source 83 may be rechargeable power sources.

FIG. 8 shows another exemplary embodiment of the fluid delivery device10 including an electronic module 300 including the local processor 50and other electronic devices in a modular subassembly, which simplifiesmanufacture, provides protection from water or other fluid damage, andprovides shielding and protection from electromagnetic interference andstatic discharge. Attached to the electronic module 300 and connected tothe communication element 60 is an optional antenna 61 to enhancetransmitting of signals from the fluid delivery device 10 via thecommunication element 60. Alternatively, antenna 61 may be integratedinto electronic module 300.

The device of FIG. 8 includes an alarm transducer 223, such as a beeperor vibration device, which is also integrated into the electronic module300. The electronic module 300 is shown encapsulated by an electronicmodule housing 301, which is a portion of the housing 20. The electronicmodule housing 301 can easily be made to be waterproof, potentially byencapsulating the entire assembly in potting material, and can beprotected with shielding material or coating for the electronic module300 to resist electromagnetic interference and electrostatic dischargewithout having to encapsulate the entire internal portion of the fluiddelivery device 10. Alternatively, the housing 20, in the portionsurrounding the electronic module 300 can be shielded or madewaterproof, potentially by using a gasket material. The optional antenna61, which can be included internal or external to the shieldingmaterial, is shown as external. The electronic module 300 may include amicroprocessor, logic circuitry, read only memory, writeable memory,random access memory, analog to digital conversion circuitry, amultiplexer, the power supply 80, resistors, capacitors, semiconductorcomponents, programmable gate arrays, operational amplifiers and variousother analog and digital electronic components.

FIG. 8 a shows a transparent window 22 included in the housing 20 of thefluid delivery device 10 of FIG. 8, which allows a user to visuallyinspect the reservoir 30. Also shown is an information barcode 26, whichhas information that can be read by a remote control device 100 providedwith a barcode scanner. Information on the barcode 26 can includeamount, type and concentration of drug contained in the reservoir, thedevice manufacturer and serial number, and expiration dates, and variousother pieces of information relative to infusion of liquid medicinesinto mammalian patients.

FIG. 9 shows another exemplary embodiment of the fluid delivery device10 which includes a housing 200 having flexible hinged sections 23 thatallow the fluid delivery device 10 to flex during patient movement toprevent detachment and aid in patient comfort. The hinged sections 23run along the length of the housing 20 and allow the fluid deliverydevice 10 to have flex along each axis of the hinged sections 23.Directions of the axes of the hinged sections 23 can be varied toprovide optimum flexibility for various patient contours and areas ofplacement.

FIG. 9 a shows a standard transcutaneous infusion set 400 consisting ofa penetrating cannula 405, usually consisting of a needle bent to ninetydegrees, a flexible tubing 404 and a Luer connector 401, which includesstandard threads 402. The infusion set 400 may also include means forattaching to the skin of a patient, such as infusion set wings 403,which may have adhesive pads on their bottom side, or may be simplytaped to the skin. This connection to the skin may not be necessary whenused with fluid delivery device 10 with recessed housing 200. Infusionset 400 can be attached to fluid delivery device 10 by connecting theinfusion set Luer connector 401 to the Luer connector 71 of the exitport assembly 70 of the device 10.

FIG. 10 shows another exemplary embodiment of the fluid delivery device10 including a means for stopping flow without requiring use of theremote control device 100. In this embodiment, the means comprises a“t-shaped” stop button 230 that protrudes through the housing 20 and ismaintained in a deactivated position through the force of stop buttonspring 231 The spring 231 is positioned between the stop button 230 anda portion 24 of the housing 20. Under normal conditions, fluid exits thedispenser 40, travels through the exit port tubing lumen 74 and exitsthe exit port assembly 70 unencumbered by stop button 230. As is shownin FIG. 10 a, when stop button 230 is pressed such that it overcomes theforce of the stop button spring 231, the stop button 232 compresses theexit port tubing lumen 74 against a second portion 25 of the housing 20,until the exit port tubing lumen 74 is fully occluded. In the embodimentshown, the stop button 230 protrudes through the housing 20.Alternatively, the device can be constructed such that, in thedeactivated position, the stop button 230 is flush with the housingouter surface 21 to prevent undesired occlusion of flow by inadvertentpressing of the stop button 230. The button size and shape can bedesigned to accommodate an index finger, or the point of a pen. Inaddition, additional features can be added to have the button 230 latchand hold after being pressed against the lumen 74. The latching featurecan be reversible, or can required removal and disposable of the fluiddelivery device 10.

FIG. 11 shows another exemplary embodiment of the fluid delivery device10 including a means for delivering a fixed amount of fluid withoutrequiring use of the remote control device 100. In certaincircumstances, it may be desirable to administer a specific volume orbolus of fluid on demand without the use of the remote control device100. Described here is an embodiment 10 wherein the user can press amechanical bolus button 180 to release the bolus of the intendedmedicine.

As also shown in FIG. 11 a, the bolus button 180 is t-shaped andprotrudes through the housing 20. The button 180 is maintained in adeactivated position through the force of bolus button spring 181positioned between the bolus button 180 and an internal portion of thehousing 20. The bolus button 180 is attached to a bolus release finger183 via a pivoting bolus lever 187. The bolus lever 187 has a pivot 182attached to the housing 20, and moves the bolus release finger 183 awayfrom a bolus delivery tubing lumen 186 and a bolus button stop 28 of thehousing when the bolus button 180 is depressed against the spring 181.The bolus delivery tubing 186 is in fluid communication with the exitport tubing lumen 74 and, thus, the exit port assembly 70. When bolusbutton 180 is not pressed, the bias from bolus button spring 181 causesthe bolus release finger 183 to press against bolus delivery tubinglumen 186 which presses against the bolus button stop 28 to occlude thebolus delivery tubing lumen 186.

In order to deliver a fixed amount of fluid when the bolus button 180 ispressed, a bolus flow restrictor 184 and a bolus volume accumulator 185are provided in the bolus delivery tubing 186. The bolus flow restrictor184 acts as a flow limiter to prevent free flow of fluid from thereservoir 30, and creates a minimum lock-out period between full bolusvolumes. Assuming in this particular embodiment that the reservoir 30 ismaintained at a pressure above atmospheric pressure, the flow rate ofthe flow restrictor 184 is chosen to be much slower than the rate atwhich the bolus volume should be delivered.

The bolus volume accumulator 185 expands with the inflow of fluid fromthe flow restrictor 184 as long as the bolus release finger 183 isoccluding the bolus delivery tubing 186. The amount of expansion of thebolus volume accumulator 185 equals the bolus volume to be delivered.When the bolus button 180 is depressed, the bolus volume of fluidmaintained in the bolus volume accumulator 185 is dispensed through thebolus delivery tubing lumen 186 and out of the exit port assembly 70.

The time to dispense the bolus dose should be short since there are nodownstream flow restrictors, and the user could be instructed to holdthe button down for a required time, not more than a few seconds.Alternative designs could latch the bolus button 180 for a specificamount of time only, as the button must be released to prevent continuedflow via the flow restrictor 184. After the bolus button 180 is pressed,bolus volume accumulator 185 fluid is delivered until the pressure inbolus volume accumulator 185 reaches atmospheric pressure. Release ofbolus button 180 causes the bolus lever 187 to rotate back, pivotingaround bolus pivot 182 until bolus release finger 183 is occluding bolusdelivery tubing lumen 186 by pressing it against housing button stop 28.Bolus volume accumulator 185 again expands an amount equal to the nextbolus volume to be delivered as fluid from reservoir 30 passes throughbolus flow restrictor 184 until the pressure in bolus volume accumulator185 equals the pressure in reservoir 30.

In FIGS. 11 and 11 a, the bolus button 180 is shown protruding throughhousing 20. Alternatively, in the deactivated position, bolus button 180may be flush with the housing outer surface 21 to prevent undesiredbolus delivery by inadvertent pressing of bolus button 180. In addition,while the figure shows a design that allows multiple depressions of thebolus button 180, alternative designs can make the bolus button 180activation a one-time event, requiring the user to replace the fluiddelivery device 10 or locate the remote control device 100.

FIGS. 12 and 12 a depict a exemplary embodiment of the remote controldevice 100 of the present invention. The remote control device 100 is ahand held device that includes a controller housing 102, on which ismounted a visual display 110, such as a liquid crystal display or LCD.The visual display 110 can visually indicate status of programming,amounts, timing, and other parameters of medicinal fluid delivery. Otherinformation can include time of day, address book, to do lists, andcalendar information and potentially an entertainment interface such asa computer game. Another use of the visual display 110 is to displayinformation received or to be sent to devices other than the fluiddelivery device 100, such as a glucometer used by diabetic patients orother diagnostic device, especially those whose information is relatedto the desired infusion rates and volumes to be delivered by fluiddelivery device 10. The remote control device 100 may have a diagnosticdevice, such as a blood glucose monitor or glucometer, or an implantableglucose sensor reader, integrated into it, simplifying the requirementsof the patient by not having to carry and maintain two separate devices.Other diagnostic devices include but are not limited to blood diagnosticdevices, electrocardiography devices and readers, electroencephalogramor EEG devices and readers, blood pressure monitors and pulse oxymetrydevices. Alternative to full integration of the diagnostic device, wouldbe connection to the device via wireless or hardwired communicationmeans, to perform a transfer of information.

The visual display 110 can also include information such as warning andalarm conditions based on the status of the fluid delivery device 100.Elements such as indicator lights, buzzers, and vibrational alarms mayalso be included in the remote control device 100 as alternative orredundant means for communicating information to the user.

The user can get information and adjust the programming of the device bydepressing various electromechanical switches also mounted on controllerhousing 102. These switches may be joined in a bank of switches andincluded in membrane keypad 120 as shown in FIGS. 11 and 11 a and as iscommon with hand held electronic devices. It is preferred that thechoice of electromechanical switches of the membrane keypad 120interface with the visual display 110 in a menu driven fashion makingreading information and programming the device more user friendly forthe user. In an alternative embodiment, the visual display 110 andmembrane keypad 120 can be combined into a single device such as a touchscreen display, also common to electronic devices. Combination of touchscreen displays, membrane keypads and singular switches may all beintegrated into the remote control device 100.

The remote control device 100 may include various electromechanicaljacks, which can accept electromechanical plugs from various devices.Shown in the figure are three plugs, a bar code reader 140, a glucometerport 150 and a computer port 170. These ports can allow two way transferof information to enhance the capabilities of remote control device 100and improve its user friendliness. FIG. 12 a shows a schematic crosssection of the remote control device 100. The membrane keypad 120 andvisual display 110 are attached to the controller electronics 105.Depicted is glucometer port 150 attached to the controller electronics105. Bar code reader 140 and computer port 170 are also attached to thecontroller electronics, not shown. The controller electronics aremounted and soldered to the controller printed circuit board 101 as isthe controller communication element 160.

The controller communication element 160 is designed to transmitsignals, or information to the communication element 60 of the fluiddelivery device 10. The controller electronics 105 act as a “translator”in translating user inputs received through the user interfaces 120 intosignals for transmission by the controller communication element 160. Ina preferred embodiment, both the communication element 60 and thecontroller communication element 160 are two way communicationassemblies allowing two way communication between the remote controldevice 100 and fluid delivery device 10. In order to send wirelessinformation the communication element 60 and the controllercommunication element 160 may include inductive wire loops or othertransmitting antenna means. Information can be sent using amplitude orfrequency modulation, and can be broadcast in the radio frequency, or RFrange. Standard information confirmation techniques such as handshakingor checksum protocols can be used to insure accurate informationtransfer. With two-way communication, when errors are detected, thetransfer can be repeated until acceptable, a similar technique to thatutilized with two way pager technology commonplace today.

If the fluid delivery device 10 is prefilled prior to patient use, theelectronic memory of local processor 50 may contain informationregarding the fluid including but not limited to type or name,concentration, amount, volume, additional drugs in solution and anydiluting agents. This information can be transmitted from the fluiddelivery device 10 via its communication element 60, and uploaded intothe remote control device 100 via its controller communication element160. Other information may be factory installed into the fluid deliverydevice 10 including but not limited to manufacturing date, expirationdate, sterilization date, therapy information such as defined flowprofiles and even patient or hospital information. This information canbe uploaded into the remote control device 100 as described above, andthe remote control device 100 may adjust its internal programming basedon the information received.

In a preferred embodiment, the electronic memory of the fluid deliverydevice 10 includes the latest program of the remote control device 100available at the time of manufacture of the fluid delivery device 10.Similarly, the electronic memory of the remote control device 100includes the latest program of the fluid delivery device 10, availableat the time of manufacture of the remote control device 100. At thefirst communication between the remote control device 100 and the fluiddelivery device 10, a program check is performed, and if a newersoftware version for either device is available from the other device,and the existing hardware is compatible, another feature which can beprogrammed into both devices, the newer program is downloaded intomemory and used by the upgraded device. The embedded program may becontained in read only memory, or ROM, while the downloaded program canbe written into electronically writeable memory. The automatic updatefeature, available for each device to upgrade the other, is another wayto make sure the user has the best available product for use.

Another advantageous feature associated with two way communication isthe addition of a proximity alarm. The design of the fluid deliverydevice 10 and remote control device 100 electronics can be such thatwhen the distance between the two devices is greater than a particularradial length, one or both of the devices will alert the user,potentially with an audio alarm. The alarming distance should be chosenso that it is less than the maximum communication range of the twodevices. A method of creating the alarm is for the fluid delivery device10 to send out frequent packets of information at a predetermined rateand at an amplitude or power less than the normal communication power,providing a safety margin for the proximity detection. The remotecontrol device 100 is programmed to expect to receive this communicationat the predetermined rate, and lack of receipt of one or more of thesepackets, causes the remote control device 100 to activate its audioalarm 106. Alternatively or additionally, a vibrational alarm may beincluded. Proximity alarms may be included that do not require two waycommunication, by integrating a device such as a magnet into the housing20 of fluid delivery device 10, and integrating magnetic field detectionmeans into the remote control device 100. When the magnetic fielddetection means of the remote control device 100 do not detect thepresence of the magnetic field of the fluid delivery device 10, theremote control device 100 activates the controller audio alarm 106.

The remote control device 100 includes a controller power supply 108that powers the various electronic components including the controllerelectronics 105, controller audio alarm 106. The controller power supply108 may be a standard battery and in the preferred embodiment, the powersupply 108 may be replaceable by the user by removing a battery door,not shown, and replacing after power supply 108 is inserted andattached. In an alternative embodiment, the power supply is integratedinto the remote control device 100, and can be recharged with a separatedevice or contains enough power to supply the device for its intendedlength of use.

The fluid delivery device 10 of the present invention may be sold tohospitals, pharmacies, outpatient centers or the patients themselves. Ifthe fluid delivery device is intended for short term or disposable use,it may be practical to sell each device with various accessories orgroups of accessories that are convenient for the user. It may bedesirable for certain parts of the fluid delivery device, or accessoriessuch as an attachable transcutaneous infusion set, such as thatdescribed hereinabove, to be packaged sterilized in a protectivepackaging. Proper aseptic maintenance of the portion of the skin thatreceives the transcutaneous access is important to prevent infection.FIGS. 13, 13 a, 13 b and 13 c depict various components that may bepackaged together in kit form.

FIG. 13 shows the fluid delivery device of the present inventionincluding means for viewing the status of the reservoir 30 and aninformation barcode 26 with a sterilized device in a sterile assemblypack 350. The device may be packaged separately or with various otherkit components. The fluid delivery device may be packaged sterileentirely in a device pouch 351, intended to allow sterilization andmaintain sterility. Such pouches often are constructed of materials suchas TYVEK, a product of Dupont. The sterile assembly pack 350 consists ofthe fluid delivery device 10 of the present invention, sealed in thedevice pouch 351 as is shown in FIG. 13. Alternatively, a portion of thefluid delivery device surrounding the exit port assembly 70 may becovered, sealed and sterilized with a sterility maintaining covering(not shown).

The top of the housing 20, or housing top side 203 includes a housingtransparent window 22 located above the reservoir 30. The transparencyof the housing transparent window 22 and design of the reservoir 30 aresuch that the patient can determine information regarding status of thereservoir 30 by viewing through the housing transparent window 22. Suchinformation can include amount of drug remaining or presence of a leak.Alternatively, the entire housing 20 may be transparent yielding similarvisual indications.

Also included in the fluid delivery device 10 of this embodiment is aninformation barcode 26 which can include various pieces of informationregarding the status of that particular fluid delivery device 10 such astype, volume and concentration of drug prefilled in the device,expiration date of device or drug, manufacture date of device or drug,serial numbers, lot numbers, hospital name, clinician name, patientname, prescription requirements and various other pieces of information.The barcode information can be read into a hospital or home computer, orin the preferred embodiment is uploaded via a barcode reader integral tothe remote control device 100. The fluid delivery device 10 and remotecontrol device 100 electronics and programming can be designed such thatthe bar code must be read prior to programming or otherwise using thefluid delivery device 10. This feature can greatly reduce programmingerrors such as those associated with the patient entering druginformation. If the patient were to enter a drug concentration that wasincorrect, and did all the remaining programming in units of drug,instead of volume, which is common practice, while the device wouldfunction properly, all of the volumes delivered would be inaccuratebased on the ratio of the incorrect concentration entered versus thetrue concentration of the drug being delivered. Many drugs are availablein multiple concentrations such as insulin often made available topatients in 40, 50 and 100 units per ml concentrations.

FIG. 13 a shows the remote control device 100 of the present inventionthat could be packaged or provided as a kit with one or more of sterilepackage assembly 350, including at least one fluid delivery device 10.There is no need for the remote control device 100 to be sterilized, soif the fluid delivery device 10 was sterilized, one or more sterilepackage assembly 350 can be boxed or otherwise packaged with a singleremote control device 100 along with one or more other devices 10.

FIG. 13 b shows a therapeutic fluid supply 250, which may consist of avial of drug such as insulin. The drug, in one or more vials, which hasbeen sterilized and made otherwise biocompatible for use, can bepackaged with one or more sterile package assemblies 350 as well as withone or more remote control devices 100. Additional devices may beincluded in the kit if desired.

FIG. 13 c shows a sterile infusion set assembly 407 including thetranscutaneous infusion set 400 described hereinabove packaged in aninfusion set pouch 406. The infusion set 400 includes an infusion setLuer 401 connected to infusion set flexible tubing 404 and terminatingin an infusion set penetrating cannula 405. An optional set of infusionset wings 403 can be included to attach the infusion set 400 to thepatient's skin. In the preferred embodiment of fluid delivery device100, the transcutaneous delivery means are integrated into exit portassembly 70, however in an alternative embodiment, the exit portassembly 70 can be attached to infusion set 400. In this particularembodiment, it may be desirable to kit sterile infusion set assemblies407 with any quantity of one or more of the sterile assembly packs 350,the fluid delivery device 10, the remote control device 100 or thetherapeutic fluid supply 250.

The fluid delivery device 10 of the present invention is intended to below cost and potentially disposable. It may be advantageous for one ormore of the components to be biodegradable, since replacement of thedevice every two to five days has many advantages, it would alsogenerate a fair amount of waste. The fluid delivery device 10 mayinclude a preinstalled battery as its power supply 80. In order toprevent the battery from powering the electronics of fluid deliverydevice 10 before its intended use, a mechanical switch may be included,connecting the battery contacts to the electronics prior to programmingwith the remote control device 100. A simplistic version of the switchdesign may be an insulating material between the battery contacts ofpower supply 80 and the electrical connection to the local processor 50.The insulating material could be designed to protrude through housing20, and be removable by the user, not shown. The user could pull theinsulating material and remove it, simultaneously connecting the batterycontacts with the electrical connection to the local processor.

The fluid delivery device 10 of the present invention may be filled withthe therapeutic fluid by the device manufacture, a pharmaceuticalcompany, or another manufacturer prior to its shipment to the hospital,pharmacy or patient. Certain drugs require refrigeration or otherspecial environmental conditions, requiring the prefilled fluid deliverydevice to be refrigerated or otherwise handled to meet specialrequirements. Insulin is a drug that requires refrigeration if it is tobe stored for a prolonged period of time. Hoechst, of Frankfurt Germany,is developing insulin that is stable at higher temperatures. Drugs thatare stable at room temperature, such as the developmental insulin ofHoechst, allow simple filling and handling of the fluid delivery device10, greatly simplifying the requirements for the patient.

Various methods of using the fluid delivery device 10 are included inthe present invention and described above. The method of programming thefluid delivery device 10 with remote programmer 100 as well as theattachment and use of the peripheral devices including transcutaneousinfusion sets and diagnostic devices such as glucometers are described.Also relevant is the ability to update the internal programming ofeither the fluid delivery device 10 or the remote control device 100 bythe corresponding device. Methods of filling the fluid delivery device10 with therapeutic fluid during the manufacturing process as well as bythe user have been described. Methods and timing of sterilization andpackaging of part or all of the fluid delivery device 10 and therapeuticfluid have also been described.

Although exemplary embodiments of the invention have been shown anddescribed, many changes, modifications and substitutions may be made bythose having ordinary skill in the art without necessarily departingfrom the spirit and scope of this invention. For example, the fluiddelivery device of this invention is intended to be low cost, lightweight, simple to use and potentially disposable by removing a majorityof the user interface, including electromechanical switches, from thefluid delivery device, and including a separate controller to replacethose functions. A reservoir, fluid dispenser, transcutaneous fluidadministration means, solid state electronics and wirelesscommunications are included in the fluid delivery device to perform itsintended function. While various means for reservoir construction,pressurization means, fluid pumping means, fluid metering means,transcutaneous delivery, electronic control and wireless communicationshave been discussed in this application, alternatives to each of theseareas can be made without departing from the spirit of the invention.

In addition, where this patent application has listed the steps of amethod or procedure in a specific order, it may be possible (or evenexpedient in certain circumstances) to change the order in which somesteps are performed, and it is intended that the particular steps of themethod or procedure claims set forth hereinbelow not be construed asbeing order-specific unless such order specificity is expressly statedin the claim.

1. A remote control device for successively providing flow instructionsto at least two disposable fluid delivery devices, comprising: userinput components for receiving user inputs regarding flow instructionsfor the fluid delivery devices; a wireless transmitter for transmittingthe flow instructions for the fluid delivery devices; and a remoteprocessor connected to the user input components and the wirelesstransmitter and programmed to assemble the flow instructions for thefluid delivery devices based upon the user inputs received through theuser input components, and transmit the flow instructions successivelyto the fluid delivery devices through the wireless transmitter; whereinthe remote processor includes a computer program comprising a set ofinstructions and wherein said set of instructions can be modified by thefluid delivery devices.
 2. A system for delivering fluidtranscutaneously to a patient including the remote control device ofclaim 1 and further comprising at least two fluid delivery devices voidof user input components.
 3. The remote control device of claim 1,wherein the user input components include a membrane keypad.
 4. Theremote control device of claim 1, wherein the user input componentsinclude a touch screen display.
 5. The remote control device of claim 1,wherein the remote processor includes programming for updating one ormore computer programs of the fluid delivery devices.
 6. The remotecontrol device of claim 1, wherein the flow instructions for the fluiddelivery devices include a variable rate infusion of fluid.
 7. Theremote control device of claim 1, wherein the remote processor isfurther programmed to transmit the flow instructions simultaneously tothe fluid delivery devices through the wireless transmitter.
 8. Theremote control device of claim 1, wherein the wireless transmitterutilizes radio frequency signals.
 9. The remote control device of claim1, further comprising a wireless receiver for receiving flow informationfrom the fluid delivery devices, and wherein the remote processor isconnected to the wireless receiver and further programmed to receive theflow information from the fluid delivery devices through the wirelessreceiver.
 10. The remote control device of claim 9, wherein the remoteprocessor is programmed to receive the flow information successivelyfrom the fluid delivery devices through the wireless receiver.
 11. Theremote control device of claim 9, wherein the remote processor isprogrammed to receive the flow information simultaneously from the fluiddelivery devices through the wireless receiver.
 12. The remote controldevice of claim 1, further comprising an input port for connecting witha physiologic sensor separate from the remote control device, andwherein the remote processor is connected to the input port andprogrammed to receive physiologic information from the physiologicsensor through the input port.
 13. The remote control device of claim12, wherein the physiologic information is blood glucose information.14. The remote control device of claim 1, further comprising a bloodglucose sensor adapted to receive a tool containing a blood sample andprovide a blood glucose measurement, and wherein the remote processor isconnected to the blood glucose sensor and programmed to receive theblood glucose measurement.
 15. The remote control device of claim 1,wherein the remote processor further comprises programming to perform auser function unrelated to the flow instructions.
 16. The remote controldevice of claim 15, wherein the user function is a non-medical function.17. The remote control device of claim 16, wherein the user functioncomprises at least one of an electronic calendar, an electronic addressbook, an electronic to do list, an email function, an internet accessfunction, a wireless telephone function, and an electronic gamefunction.
 18. A remote control device for successively receiving flowinformation from at least two disposable fluid delivery devices,comprising: user output components for providing user outputs regardingflow information from the fluid delivery devices; a wireless receiverfor receiving the flow information from the fluid delivery devices; anda remote processor connected to the user output components and thewireless receiver and programmed to successively receive the flowinformation from the fluid delivery devices through the wirelessreceiver and convert the flow information to user outputs and providethe user outputs to the user output components; wherein the remoteprocessor includes a computer program comprising a set of instructionsand wherein said set of instructions can be modified by the fluiddelivery devices.
 19. A system for delivering fluid transcutaneously toa patient including the remote control device of claim 18 and furthercomprising at least two fluid delivery devices void of user outputcomponents.
 20. The remote control device of claim 18, wherein the useroutput components include at least one of a liquid crystal display, alight emitting diode, a vibrational transducer and an audio transducer.21. The remote control device of claim 18, wherein the user outputcomponents include a touch screen display.
 22. The remote control deviceof claim 18, wherein the remote processor includes programming that canmodify the set of instructions that comprise one or more programs of thefluid delivery devices.
 23. The remote control device of claim 18,wherein the flow information includes variable rate infusion of fluidinformation.
 24. The remote control device of claim 18, wherein theremote processor is further programmed to receive the flow informationsimultaneously from the fluid delivery devices through the wirelessreceiver.
 25. The remote control device of claim 18, wherein thewireless receiver utilizes radio frequency signals.
 26. The remotecontrol device of claim 18, further comprising a wireless transmitterfor transmitting flow instructions to the fluid delivery devices, andwherein the remote processor is connected to the wireless transmitterand further programmed to transmit the flow instructions to the fluiddelivery devices through the wireless transmitter.
 27. The remotecontrol device of claim 26, wherein the remote processor is programmedto transmit the flow instructions successively to the fluid deliverydevices through the wireless transmitter.
 28. The remote control deviceof claim 26, wherein the remote processor is programmed to transmit theflow instructions simultaneously to the fluid delivery devices throughthe wireless transmitter.
 29. The remote control device of claim 18,further comprising an input port for connecting with a physiologicsensor separate from the remote control device, and wherein the remoteprocessor is connected to the input port and programmed to receivephysiologic information from the physiologic sensor through the inputport.
 30. The remote control device of claim 29, wherein the physiologicinformation is blood glucose information.
 31. The remote control deviceof claim 18, further comprising a blood glucose sensor adapted toreceive a tool containing a blood sample and provide a blood glucosemeasurement, and wherein the remote processor is connected to the bloodglucose sensor and programmed to receive the blood glucose measurement.32. The remote control device of claim 18, wherein the remote processorfurther comprises programming to perform a user function unrelated tothe flow information.
 33. The remote control device of claim 32, whereinthe user function is a non-medical function.
 34. The remote controldevice of claim 33, wherein the user function comprises at least one ofan electronic calendar, an electronic address book, an electronic to dolist, an email function, an internet access function, a wirelesstelephone function, and an electronic game function.
 35. A remotecontrol device for successively providing flow instructions to, andreceiving flow information from, at least two disposable fluid deliverydevices, comprising: user input components for receiving user inputsregarding flow instructions for the fluid delivery devices; user outputcomponents for providing user outputs regarding flow information fromthe fluid delivery devices; a wireless transmitter for transmitting theflow instructions for the fluid delivery devices; a wireless receiverfor receiving the flow information from the fluid delivery devices; anda remote processor connected to the user input components, the useroutput components, the wireless transmitter, and the wireless receiver,and programmed to successively communicate with the fluid deliverydevices and, assemble the flow instructions for each of the fluiddelivery devices based upon the user inputs received through the userinput components, and transmit the flow instructions to the fluiddelivery device through the wireless transmitter, and receive the flowinformation from each of the fluid delivery devices through the wirelessreceiver and convert the flow information to user outputs and providethe user outputs to the user output components; wherein the remoteprocessor includes a computer program comprising a set of instructionsand wherein said set of instructions can be modified by the fluiddelivery devices.
 36. A system for delivering fluid transcutaneously toa patient including the remote control device of claim 35 and furthercomprising at least two fluid delivery devices void of user inputcomponents and void of user output components.
 37. The remote controldevice of claim 35, wherein the user input components include a membranekeypad.
 38. The remote control device of claim 35, wherein the userinput components include a touch screen display.
 39. The remote controldevice of claim 35, wherein the remote processor includes programmingfor updating one or more computer programs of the fluid deliverydevices.
 40. The remote control device of claim 35, wherein the flowinstructions for the fluid delivery devices include a variable rateinfusion of fluid.
 41. The remote control device of claim 35, whereinthe wireless transmitter utilizes radio frequency signals.
 42. Theremote control device of claim 35, further comprising an input port forconnecting with a physiologic sensor separate from the remote controldevice, and wherein the remote processor is connected to the input portand programmed to receive physiologic information from the physiologicsensor through the input port.
 43. The remote control device of claim42, wherein the physiologic information is blood glucose information.44. The remote control device of claim 35, further comprising a bloodglucose sensor adapted to receive a tool containing a blood sample andprovide a blood glucose measurement, and wherein the remote processor isconnected to the blood glucose sensor and programmed to receive theblood glucose measurement.
 45. The remote control device of claim 35,wherein the remote processor further comprises programming to perform auser function unrelated to the flow instructions.
 46. The remote controldevice of claim 45, wherein the user function is a non-medical function.47. The remote control device of claim 46, wherein the user functioncomprises at least one of an electronic calendar, an electronic addressbook, an electronic to do list, an email function, an internet accessfunction, a wireless telephone function, and an electronic gamefunction.
 48. The remote control device of claim 35, wherein the useroutput components include at least one of a liquid crystal display, alight emitting diode, a vibrational transducer and an audio transducer.49. The remote control device of claim 35, wherein the user outputcomponents include a touch screen display.
 50. The remote control deviceof claim 35, wherein the flow information includes variable rateinfusion of fluid information.
 51. The remote control device of claim35, wherein the wireless receiver utilizes radio frequency signals. 52.The remote control device of claim 35, wherein the remote control deviceis further programmed to confirm communication with the fluid deliverydevice.
 53. The remote control device of claim 18, wherein the remotecontrol device is further programmed to confirm communication with thefluid delivery device.
 54. The remote control device of claim 1, whereinthe remote control device is further programmed to confirm communicationwith the fluid delivery device.